The American Society for Microbiology (ASM) appreciates your leadership in forging a new federal agency to counter the threat of terrorist attacks against the United States. We are, however, writing to identify concerns raised by Amendment No. 2 to the National Homeland Security and Combating Terrorism Act of 2002, S.2452, which was approved by the Committee on Governmental Affairs on July 25. The Amendment appears to assign the proposed Department of Homeland Security (DHS) primary responsibility for prioritization and control of human biodefense related biological, biomedical, and infectious disease research. The ASM is the largest life science society in the United States with over 40,000 members. Its principal goal is the study and advancement of scientific knowledge of microbiology for the benefit of human welfare. The ASM has worked with the Administration, Congress, and federal agencies on measures to protect American citizens against biological weapons and bioterrorism. The ASM, therefore, is following closely the progress of legislation to establish the DHS and has testified in the House of Representatives concerning issues related to human health related biodefense.

The ASM supports including a science component within the DHS to provide linkage between it and the numerous mission agencies charged with science development. Biodefense research, however, is part of the continuum of the broader subject of biomedical research. It is critical that the Department of Health and Human Services (HHS), a scientific health agency, prioritize and conduct federal research including biodefense research related to civilian, human health-related biological, biomedical, and infectious diseases.HHS is best qualified to establish biomedical research and development programs and to prioritize scientific opportunities and research approaches.Transfer of primary responsibility for the prioritization and/or design of human biodefense research to DHS would create unpredictability for research programs and would not be the optimum way to obtain the integrated work of the best scientific minds, including the ability to rapidly mobilize the scientific community with the appropriate expertise.

Because the ASM believes HHS must retain the primary responsibility for human biodefense research, it strongly supports the approach of Sections 301 and 303 of the Homeland Security Act, H.R. 5005, which was approved by the House of Representatives on July 26. In that measure, HHS retains primary responsibility for research and development programs, in consultation with DHS. The ASM reviewed with great interest your Amendment regarding collaboration between DHS and HHS on human biodefense related research. Based upon that review, the ASM has the following concerns regarding the Amendment.

The Amendment establishes requirements for biodefense research conducted by the National Institutes of Health (NIH). Further, it establishes certain statutorily mandated procedures for collaboration between DHS and HHS. The cumulative effect of these provisions appears to place ultimate control over the prioritization and conduct of human biodefense research in the DHS. The ASM is concerned about the effect of the Amendment and strongly recommends that modifications be made in S. 2452 to adopt the House bill provisions to assure that HHS retains the primary role for the prioritization and conduct of human health related biodefense research in consultation and collaboration with DHS.

The ASM's concern with the impact of the Amendment arises from our review of the cumulative effect of the provisions. Although relatively brief, the Amendment does the following:

The Amendment provides that DHS may carry out human biodefense-related biological, biomedical, and infectious disease research and development. Although the Amendment provides that DHS shall collaborate with HHS, it does not specify that DHS' research must be conducted under the procedures of the Amendment or by, or under the supervision of, HHS. On the other hand, as seen immediately below, the Amendment essentially requires that HHS conduct all of its research in human biodefense-related biological, biomedical, and infectious diseases in accord with the procedures in the Amendment.

The Amendment provides that all research supported by funding appropriated to NIH for bioterrorism research must be conducted under "joint strategic prioritization agreements" with DHS. Additionally, all research programs under the Amendment must be managed and awarded by NIH consistent with such agreements. Effectively, the Amendment requires that all NIH bioterrorism research be conducted under a joint strategic prioritization agreement with DHS. Therefore, if, for any reason, DHS and HHS did not reach a mutually agreeable joint strategic prioritization agreement, NIH apparently could not conduct bioterrorism research even if Congress already appropriated funds for such research.

Regarding joint strategic prioritization agreements, the Amendment provides that DHS "shall have the authority to establish general research priorities." After DHS establishes the priorities, those priorities are to be "embodied in the joint strategic prioritization agreements." The Amendment does not require DHS to consult with HHS in establishing priorities. Therefore, the Amendment appears to give DHS full authority for establishing human health-related bioterrorism research priorities. In turn, those priorities are to be embodied in the joint strategic prioritization agreements.

Once a joint strategic prioritization agreement is reached, HHS is to develop the specific scientific research agenda to implement the agreement. However, unlike the absence of any duty for DHS to consult with HHS in establishing priorities, HHS is expressly required to consult with DHS in setting the research agenda.

DHS is permitted to transfer funds to HHS in connection with joint strategic prioritization agreements. Therefore, DHS not only establishes priorities for research and has a right to consultation on the research agenda, but also DHS may wield the power of the purse regarding bioterrorism research. HHS, acting through NIH, is restricted in its bioterrorism research to projects conducted under joint strategic prioritization agreements while DHS is not so restricted and may obtain separate appropriations for such research. Those funds may be used in DHS' collaborations with HHS to influence or control the prioritization and direction of research projects.

If the Amendment is intended to establish a partnership between DHS and HHS for the prioritization, design, and conduct of human biodefense-related biological, biomedical, and infectious disease research and development, DHS is surely the senior partner. DHS sets the priorities that, by statute, must be embodied in the joint strategic prioritization agreements. It monitors the specific research agenda established by HHS. It has the right, but not the obligation, to contribute funds for such research. Finally, DHS may have the right to carry out research outside the specific procedures of the Amendment.

The Amendment is silent on what happens if DHS and HHS are unable to arrive at a joint strategic prioritization agreement or if DHS finds that research designed by HHS does not ensure achievement of a joint agreement. Of course, everyone expects DHS and HHS to reach agreement but just as certainly, no one can be certain that deeply held differences would not arise. From a planning standpoint, one agency must be empowered to move ahead with research. ASM respectfully urges that it is critical that HHS prioritize and conduct federal research efforts related to civilian human health-related biological, biomedical, and infectious diseases.

HHS, the federal agency with the major mission for protecting the public health, is best qualified to establish biomedical research and development programs and to identify scientific opportunities and research approaches for meeting biodefense needs. HHS/NIH is best able to bring together all aspects of biomedical research and the full capability of science to ensure breakthroughs and advances of high quality for biodefense. The ability to build on the body of scientific knowledge and the existing research infrastructure in infectious diseases sponsored by NIH underpins the capability of the United States to combat bioterrorism. The response to bioterrorism will require the long-term dedication of financial resources and scientific talent. HHS/NIH has already demonstrated its capacity for such service. For example, the national response mounted by NIH/NIAID to AIDS demonstrates the capability of science to respond to a threat. The response was based on years of accumulated scientific knowledge and biomedical research that had been well supported by Congress.

HHS/NIH, working in consultation with the DHS, has the knowledge about scientific capabilities to respond to threats and vulnerabilities related to the biological sciences. It can identify the science and infrastructure relevant to the most pressing issues and take advantage of the most highly leveraged opportunities for research that can contribute to counter-terrorism solutions. Because it is difficult to distinguish an introduced infectious disease from a naturally occurring one, the strategies to protect against either event in terms of new scientific and technical approaches, including surveillance, prevention and response, are the same. There will be dual benefits for public health in that investment in research to develop new therapeutics, vaccines, antivirals, genomics, diagnostics, sensitive detection devices and innovative surveillance approaches for biological agents will carry over to public health breakthroughs for all infectious diseases.

The nation has already seen the ability of HHS to respond to bioterrorism. In the months since September 11, 2001, the NIAID has rapidly accelerated work to protect the nation against the threat of bioterrorism. This acceleration has occurred across the spectrum of scientific activities from basic research in microbial biology to the development of vaccines and therapeutics to research related to diagnostic systems. It is critical that this work continue to develop rapidly and efficiently without delay, disruption or loss of momentum.

A scientific health agency, HHS, rather than the nonscientific, nonpublic health DHS should have the principal authority for developing and prioritizing scientific and health related programs. Therefore, the ASM suggests reversing the primary responsibilities identified in Amendment. HHS should retain responsibility for biodefense research and development programs. HHS should consult and coordinate with DHS. In the final analysis, ultimate responsibility should reside within HHS for prioritization and control of human biodefense-related biological, biomedical, and infectious disease research and development as recommended in the House bill.

In closing, the ASM again thanks you for your leadership and affirms its commitment to working with you and members of the Senate, House, and the Administration to achieve the most efficient and effective system in the world for research, control, and response to the threat posed by biological agents. ASM will be pleased to provide any assistance you may desire in considering the vital issues arising from the threat of bioterrorism.